FDA News

FDA approves Lynparza, companion diagnostic for BRCA-mutated ovarian cancer

Jonathan Lancaster, MD, PhD
Johnathan Lancaster

The FDA today approved olaparib for the maintenance treatment of women with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

The FDA also approved BRACAnalysis CDx (Myriad Genetic Laboratories) as a companion diagnostic for olaparib (Lynparza; AstraZeneca, Merck) — a poly(ADP ribose) polymerase inhibitor — to identify patients with advanced ovarian cancer who harbor a germline BRCA mutation.

“We congratulate AstraZeneca and Merck on obtaining FDA approval of Lynparza for patients with BRCA-mutated advanced ovarian cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test in this population,” Lloyd Sanders, president of Myriad Oncology, said in a press release. “We estimate there are more than 20,000 patients newly diagnosed with ovarian cancer in the United States every year who qualify for a BRACAnalysis CDx test.”

These FDA approvals were based on results from the randomized, double-blind, placebo-controlled, multicenter SOLO-1 trial. Patients with BRCA-mutated advanced ovarian, fallopian tube or primary peritoneal cancer received 300 mg olaparib tablets orally twice daily (n = 260) or placebo (n = 131) following first-line platinum-based chemotherapy.

As HemOnc Today previously reported, results showed olaparib maintenance reduced the risk for progression or death by 70% (HR = 0.3; 95% CI, 0.23-0.41). Estimated median PFS was not reached in the olaparib group and was 13.8 months in the placebo group.

OS data are not yet mature.

“Women with ovarian cancer are often first diagnosed with advanced disease, which is associated with poor outcomes,” Dave Fredrickson, executive vice president and head of the oncology business unit of AstraZeneca, said in a press release. “Today’s approval is a critical advancement and brings us closer to our goal of helping these patients achieve long-term remission.”

The most common any-grade adverse events associated with olaparib included nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia, decreased appetite, dizziness, neutropenia, dyspepsia, dyspnea, urinary tract infection, leukopenia, thrombocytopenia and stomatitis.“In the SOLO1 trial, Myriad’s BRACAnalysis CDx test identified patients with advanced ovarian cancer who may benefit from Lynparza,” Johnathan Lancaster, MD, PhD, gynecologic-oncologist and chief medical officer of Myriad Genetics, said in a press release. “The FDA’s approval underscores the need for all patients with ovarian cancer to know their BRACAnalysis CDx results at the time of diagnosis so they can fully understand their treatment options.”

The ongoing phase 3 PAOLA-1 trial is testing olaparib with bevacizumab (Avastin, Genentech) as a maintenance treatment for patients with newly-diagnosed, advanced ovarian cancer, regardless of their BRCA status. Officials expect results of that trial during the second half of 2019.


Jonathan Lancaster, MD, PhD
Johnathan Lancaster

The FDA today approved olaparib for the maintenance treatment of women with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

The FDA also approved BRACAnalysis CDx (Myriad Genetic Laboratories) as a companion diagnostic for olaparib (Lynparza; AstraZeneca, Merck) — a poly(ADP ribose) polymerase inhibitor — to identify patients with advanced ovarian cancer who harbor a germline BRCA mutation.

“We congratulate AstraZeneca and Merck on obtaining FDA approval of Lynparza for patients with BRCA-mutated advanced ovarian cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test in this population,” Lloyd Sanders, president of Myriad Oncology, said in a press release. “We estimate there are more than 20,000 patients newly diagnosed with ovarian cancer in the United States every year who qualify for a BRACAnalysis CDx test.”

These FDA approvals were based on results from the randomized, double-blind, placebo-controlled, multicenter SOLO-1 trial. Patients with BRCA-mutated advanced ovarian, fallopian tube or primary peritoneal cancer received 300 mg olaparib tablets orally twice daily (n = 260) or placebo (n = 131) following first-line platinum-based chemotherapy.

As HemOnc Today previously reported, results showed olaparib maintenance reduced the risk for progression or death by 70% (HR = 0.3; 95% CI, 0.23-0.41). Estimated median PFS was not reached in the olaparib group and was 13.8 months in the placebo group.

OS data are not yet mature.

“Women with ovarian cancer are often first diagnosed with advanced disease, which is associated with poor outcomes,” Dave Fredrickson, executive vice president and head of the oncology business unit of AstraZeneca, said in a press release. “Today’s approval is a critical advancement and brings us closer to our goal of helping these patients achieve long-term remission.”

The most common any-grade adverse events associated with olaparib included nausea, fatigue, abdominal pain, vomiting, anemia, diarrhea, upper respiratory tract infection/influenza/nasopharyngitis/bronchitis, constipation, dysgeusia, decreased appetite, dizziness, neutropenia, dyspepsia, dyspnea, urinary tract infection, leukopenia, thrombocytopenia and stomatitis.“In the SOLO1 trial, Myriad’s BRACAnalysis CDx test identified patients with advanced ovarian cancer who may benefit from Lynparza,” Johnathan Lancaster, MD, PhD, gynecologic-oncologist and chief medical officer of Myriad Genetics, said in a press release. “The FDA’s approval underscores the need for all patients with ovarian cancer to know their BRACAnalysis CDx results at the time of diagnosis so they can fully understand their treatment options.”

The ongoing phase 3 PAOLA-1 trial is testing olaparib with bevacizumab (Avastin, Genentech) as a maintenance treatment for patients with newly-diagnosed, advanced ovarian cancer, regardless of their BRCA status. Officials expect results of that trial during the second half of 2019.